WTC NRHP contract PWS.pdf

WTC National Responder Health Program Contract Performance Work Statement

C.1 Background

Since the tragic events of September 11, 2001, the Department of Health and Human Services (DHHS), the Centers for Disease Control and Prevention (CDC) and the National Institute for Occupational Safety and Health (NIOSH) have facilitated health evaluations for workers involved with response, recovery or clean-up operations at the World Trade Center (WTC) disaster sites. These workers have since been collectively referred to as WTC “responders”.

Health screening examinations for WTC responders began in 2002 under contracts awarded to Mount Sinai School of Medicine (MSSM) and the Fire Department of New York (FDNY).

MSSM subcontracted with other specialty occupational health clinics in New York and New Jersey to expand capacity and provide a standardized and comprehensive health screening protocol. The screening protocol included medical (physical and mental health) and exposure assessments, a physical examination, lung function assessment, chest radiography, and routine analyses of blood and urine. The program also provided occupational health education, social benefits counseling and clinical referral services as required. At that time, philanthropic funding enabled participating responders to seek definitive medical treatment. Participants were recruited through outreach efforts that included community and labor union meetings, mailings, and other media-related outlets.

General Background on the World Trade Center Program

The adverse health symptoms identified in the screening exams prompted the Congress to appropriate further funding to implement longer term medical monitoring for these WTC responders. The occupational health specialty clinics involved in the screening program were then each directly funded to work collaboratively and provide periodic standardized medical monitoring exams in 2004. Participants in the screening program were automatically enrolled in this program. In 2006, Congress appropriated additional funds for diagnostic and treatment services to support medical care for health conditions associated with WTC-related work exposures. The targeted work-related health conditions covered under the program were scientifically determined through the experience of caring for health needs of the responders and with input from experts in pertinent fields of science and medicine. The WTC-related health conditions include specific upper and lower airway diseases, esophageal disorders from acid reflux, musculoskeletal injuries, and mental health problems (most notably post-traumatic stress disorder, anxiety, and depression). The program was re-named the WTC Medical Monitoring and Treatment Program (MMTP) to reflect expanded services to the eligible responders. The planned interval between monitoring exams was decreased from 18 to 12 months to enable earlier detection and intervention for the high rates of illness detected. The intended goal was to minimize organ damage/disability and improve quality of life for those affected. The established program clinical sites were termed the “Clinical Centers of Excellence” reflecting their multidisciplinary expertise and extensive program experience with the WTC responder population.

Background on the National Responder Health Program Monitoring exams were also made available to responders living outside the greater NYC area and geographically distant from the established clinical centers. These “national responders” received services through a variety of subcontracted provider entities. The Association of

Occupational and Environmental Clinics worked collaboratively with the WTC MMTP to provide treatment services for the national responders until philanthropic funding ended in June 2008. Monitoring and treatment services for national responders were then combined into a single contract service award to manage the WTC National Responder Health Program (NRHP).

In conjunction with clinical services, the NRHP contractor’s responsibilities include customer relations which involve an information hotline, scheduling and coordination of health care needs in the program, and case management to assist with coordination of multiple health care needs.

Medical monitoring in the NRHP is implemented differently from the Clinical Centers of Excellence (Clinical Centers) because of the low numbers of responders seen by any given provider due to geographical distribution across the nation, while at the same time having the need to maintain consistency and quality. Medical monitoring is conducted in multiple steps, including a telephone interview by a health care professional trained to use a standardized health assessment tool, medical testing, and a monitoring physician encounter. The monitoring physician reviews all the information, performs a physical examination and provides a summary assessment. Responders are referred back to the NRHP contractor if further services are needed for diagnosis or treatment of WTC-related health conditions. The contractor then schedules the services, including routine disease management, specialty consultation, pharmacy benefits and case management.

Process Flow in the WTC MMTP

Figure C.1-1 illustrates the process flow for a responder in the WTC MMTP.

Program Verifies Eligibility and Assigns the New Responder (Member) to a Clinical Center of Excellence or the National

Program Contractor

Initial Health Assessment

(Medical Monitoring Exam)

Is a WTC Condition

Suspected?

Is Treatment Needed?

WTC

Condition?

Treatment and Pharmacy

No

Yes

No

Yes

No

A Request for Eligibility

Determination is Submitted

Social Work Counseling

Further Diagnostic Evaluation

Periodic Medical Monitoring Exam

No

Yes

Is Periodic Medical Monitoring Exam Due?

Yes

Monitor Responder’s Status and Be Available to

Answer Questions

No

Social Work Counseling

Advised to Seek Care Outside Program

(Procedure for Engaging Emergency Services)

Figure C.1-1 Process Flow in the WTC MMTP

A potential program participant completes a questionnaire about their work experience related to the 2001 WTC disaster. Their responses are reviewed to determine program eligibility and then eligible responders are enrolled in one of the Clinical Centers in the metropolitan New York City/New Jersey area, or in the NRHP for responders who do not reside near any of the Clinical Centers.

An initial monitoring exam is performed, which consists of a comprehensive medical (and mental health) history and review of current symptoms, pulmonary function test, radiography of the chest, chemical assays of blood and urine, and a physical examination and case assessment by a program physician. Interviews are also conducted for social benefits counseling, health education, and further mental health assessment, as needed. The responder is notified of the monitoring exam findings and encouraged to seek appropriate care for abnormal findings. There are processes in place for urgent notification and emergency intervention, if required. The responder is clinically referred within the WTC MMTP for further diagnostic evaluation and treatment of suspected WTC-related health conditions.

Table 1 provides information on enrollment and participation in the WTC MMTP, and the next sections briefly describe the roles and compositions of the Clinical Centers and the National Program which work together, as needed, because of the mobility of responders.

Table 1 Enrollment and Participation in the WTC MMTP as of December 31, 2009

Cohort

Enrolled

Initial Exam

Monitoring Exams in Past Year

Treatment Patients in

Past Year** FDNY Responders 15,721 15,276 10,004 4,946 NY/NJ Consortium Responders*** 32,924 27,120 11,766 7,479 National Responders (Outside NYC area)

4,212 3,126 2,238 890

Total Responders 52,857 45,522 24,008 13,315

* Enrolled refers to the total number of individuals who have met eligibility criteria to be included in the program. Not all responders have decided to participate in the monitoring program after enrolling.

** The number of patients in treatment are those responders who have been referred from a monitoring exam for follow-up care and received any treatment between January 1, 2009 and December 31, 2009.

*** NY/NJ Consortium responders are those seen in one of the following five clinical centers of excellence: New York University School of Medicine/Bellevue Hospital, City University of New York/Queens College, Mount Sinai School of Medicine, State University of New York at Stony Brook, and the University of Medicine and Dentistry of New Jersey/Robert Wood Johnson Medical School.

Clinical Centers of Excellence

There are six established Clinical Centers currently receiving funding through cooperative agreements to provide medical monitoring examinations, diagnosis, and treatment services for the WTC-related health conditions. Treatment services include physician visits, test procedures, medical devices, pharmacy benefits, case management, health education and social service counseling to eligible responders. Five of the Clinical Centers work as a clinical consortium with a standardized medical monitoring protocol approved by each center’s respective institutional review board (IRB). The clinical consortium is coordinated by MSSM through a separate cooperative agreement that funds a Data and Coordination Center for the bioinformatics data arising from the consortium. FDNY houses a Clinical Center and a Data and Coordination Center for eligible responders that were affiliated with FDNY (by employment or retirement) at the time of the WTC attack. The FDNY program is run under an IRB-approved protocol for medical monitoring and data management. As an employer-based program, FDNY must resolve any labor-management issues impacting the program. FDNY works collaboratively with the other Clinical Centers to review clinical presentations and calibrate programmatic decision-making across the practice sites. The Clinical Centers are actively engaged with labor representatives to discuss program policy and ensure sensitivity to emerging issues.

National Responder Health Program

Eligible WTC responders living outside the geographic areas covered by the Clinical Centers participate through a separate component called the National Responder Health Program (NRHP), managed through a contract. This component ensures that the national responders are provided periodic medical monitoring exams and targeted treatment services, which include routine care for WTC-related health conditions, specialty consultation, pharmacy benefits, case management, and social services information. The health data collected in this NRHP component are used clinically to inform the medical monitoring physician and to facilitate determinations of health care coverage by the contractor.

Logistics Health, Incorporated Current National Responder Health Program Contractor

La Crosse, WI

C.2 Project Objective

The objective of this WTC NRHP Contract is to provide initial and periodic medical monitoring examinations and targeted diagnostic and treatment services (including pharmacy benefits) for the specified WTC health conditions to all certified, eligible WTC responders living outside of the NYC area. These services are to be provided free of charge to the responders and will be provided in a location that is reasonably accessible to the responder. It is important to continue to provide, at a minimum, current levels of service with as little disruption to the responder as possible. Therefore, all current health care providers should be maintained, if possible.

The WTC NRHP Contractor should have in place a system for assisting responders who choose to file claims for workers’ compensation and for receiving reimbursement for medical care expenses that will be used to support the WTC RHP (see Section C.4.7.7).

C.3 Scope of Work

This section provides an overview of the work to be performed. Section C.4 contains the detailed requirements for the project. Figure C.3-1 illustrates the services to be provided.

In addition to overall project management, the NRHP contractor will provide the following services under the NRHP Contract:

WTC National Responder Healthcare Contract

Reporting

Pharmacy Benefit Case Management

Claims Processing and Bill Payment

Monitoring Exams Diagnosis and Treatment

Member Services

Figure C.3-1 Services to Be Provided Under the NRHP Contract

The NRHP contractor is responsible for directly managing medical monitoring and any subsequent diagnostic or treatment services for responders enrolled in the NRHP component of the WTC RHP. The NRHP contractor shall, at a minimum, provide comparable services to those which are currently being provided. All services and medications shall be billed on a fee-for-service basis. This means that the NRHP contractor shall pay the provider a predetermined fee.

The following services are to be provided:

• Project Management

• Initial and Annual Medical Monitoring Examinations

• Diagnostic and Treatment Services

• Pharmacy Benefit

• Case Management

• Claims Processing and Bill Payment

• Member Services o WTC Phone Bank/Hot Line o WTC ID Cards o Member Retention o Member Transfers o Medical Review and Appeals o Social Services Referrals o Workers’ Compensation Assistance o Internal Audit Function o Media Relations o Records Management

• Reporting.

C.4 Performance Work Statement

This section specifies what is required of the NRHP contractor under this Performance Work Statement (PWS).

C.4.1 Project Management

The NRHP contractor shall provide comprehensive management of all services to be provided under the NRHP Contract. This includes providing a detailed Project Management Plan that describes how the NRHP contractor will manage the Transition-in Phase, the Operations Phase, and the Transition-out Phase. The NRHP contractor shall respond to government concerns within 24 hours of notification.

C.4.1.1 Project Management Plan

The NRHP contractor shall provide a draft Project Management Plan with their proposal which describes the NRHP contractor’s plan for organizing, staffing, and managing the WTC NRHP, including an identification of key personnel with the percent of time to be devoted to the WTC NRHP Contract by each.

In addition to the Project Management Plan, the NRHP contractor shall submit a draft Fraud and Abuse Compliance Plan with their proposal. As part of the Fraud and Abuse Compliance Plan, the NRHP contractor shall:

• Designate executive and essential personnel to attend mandatory training in Fraud and Abuse detection, prevention and reporting.

• Designate an officer or director in its organization with responsibility and authority for carrying out the provisions of the Fraud and Abuse Compliance Plan.

The completed Project Management Plan and Fraud and Abuse Compliance Plan shall be submitted to NIOSH for approval within two weeks after contract award.

C.4.1.2 Key Personnel

The NRHP contractor shall designate certain project personnel as “Key Personnel” who they feel are essential to the successful accomplishment of project objectives. The NRHP contractor's Key Personnel shall include, at a minimum, a Project Manager and a Medical Director. The Medical Director shall be a licensed physician, preferably with a specialty in Occupational Medicine.

C.4.1.3 Project Personnel

The NRHP contractor shall propose labor categories and qualifications of personnel that they believe shall be required to support the Key Personnel. Examples of these labor categories include Customer Service Representatives, Case Managers, and Social Workers. Currently, Registered Nurses conduct Medical History Interviews and serve as Case Managers. Ideally, Social Workers would be able to assist with crisis management and advise on social service benefits. There may be additional expertise needed to coordinate workers’ compensation issues.

C.4.1.4 Quality Assurance

The NRHP contractor’s Project Management team shall include a Quality Assurance component.

Responsibilities of the Quality Assurance group shall include:

• reviewing all deliverables for completeness and accuracy

• measuring, monitoring, and increasing member satisfaction

• improving overall program success

• early identification and resolution of problems, issues, and risks

• monitoring of adherence to established policies and procedures

• continuous process improvement and implementation of lessons learned.

The NRHP contractor shall be responsible for developing and documenting its approach to Quality Assurance. The NRHP contractor shall perform the required services in accordance with their internal Quality Assurance Program. The contractor shall develop a project-specific Quality Assurance Plan (QAP) which describes the procedures which will be used to monitor and improve all project activities including reporting. The draft, project-specific QAP shall be submitted to NIOSH for review and approval by the end of the Transition-in Phase.

The NRHP contractor shall establish a Customer Satisfaction Survey program. Responder’s shall be given the opportunity to complete a Customer Satisfaction survey at least yearly. The offeror’s proposal shall provide details about the proposed Customer Satisfaction survey including frequency and method of surveys, corrective actions to be taken based on survey results, and reporting of survey results to NIOSH.

In addition, NIOSH shall receive no more that 2 valid complaints from responders about contractor performance during a month.

C.4.1.5 Transition-in Phase

The Transition-in Phase is defined as the period between the time of contract award and the beginning of the Operations Phase.

The NRHP contractor shall develop or inherit management and administrative processes to ensure that all required services shall be delivered on the first day of the Operations Phase. Based on the NRHP contractor’s experience and the information provided in this PWS, the NRHP contractor shall propose the expected duration of the Transition-in Phase, the tasks to be accomplished during this phase, and the schedule for completion of each proposed task.

During the Transition-in Phase the NRHP contractor shall:

• Establish the Program Management organization

• Implement the system to be used for claims processing and bill payment of the services provided under the NRHP contract

• Implement a nationwide pharmacy benefit

• Implement a nationwide health care provider network for the geographic locations of the

NRHP responders being served

• Ensure that a public relations specialist who is familiar with the program is available to handle media attention for this highly visible program

• Conduct a Readiness Review to ensure all systems and processes are in place and ready to begin the Operations Phase

• Provide NIOSH with a detailed report from the Readiness Review and provide an assurance of System and Operations Readiness

• Correct all deficiencies revealed in the Readiness Review and put procedures in place to ensure that the deficiencies shall not be repeated.

Upon contract award, NIOSH will furnish the NRHP contractor with a list of responders living outside of the NYC area who are currently in the WTC NRHP. The NRHP contractor shall contact these NRHP responders to provide information about the contractor and to verify the NRHP responder’s contact information.

During the Transition-in Phase the NRHP contractor shall provide an identification card for all NRHP responders to identify the individual as a member of the WTC RHP. These identification cards will be used by the NRHP responders to access benefits for health care and pharmacy services under the NRHP contract.

During the Transition-in Phase the NRHP contractor shall establish a phone bank to answer calls related to the WTC RHP (the NRHP Resource Line). The NRHP contractor shall propose hours of operation for the phone bank as well as qualifications and training for Customer Service Representatives (those employees assigned to answer calls coming into the phone bank). When a responder is put on “hold”, the responder’s wait time shall be no longer than 2 minutes, 95% of the time. The NRHP contractor shall also propose call routing procedures and any other details that will demonstrate the NRHP contractor’s understanding of phone bank operation. The incumbent NRHP contractor’s phone bank currently receives approximately 50 calls per day related to the WTC RHP.

NRHP Contractor’s Provider Network

During the Transition-in Phase the NRHP contractor shall establish and maintain an adequate national health care provider network to serve all NRHP responders who are or may be enrolled, to include, but not be limited to hospitals, specialty clinics, trauma centers, specialists, and primary care physicians, in sufficient numbers and at convenient locations. Covered services shall be provided by out-of-network providers if such services are not available through in-network providers.

The physicians who will be conducting the medical monitoring assessment and physical examination shall be experienced in practicing occupational medicine (e.g., conducting occupational health screening and medical surveillance); preferably credentialed as occupational medicine specialists, whenever possible. The NRHP contractor shall develop training to properly orient the participating NRHP providers about the potential exposures and health outcomes that have been associated with work related to the WTC attack (response, recovery, remediation, clean-up), and the conditions and services covered by the program.

The NRHP contractor shall be responsible for ensuring that the health care providers who provide diagnostic and treatment services meet all requirements of the NRHP Contract including complying with all requirements of Workers’ Compensation.

The NRHP contractor’s health care provider network and data system shall be flexible enough to accommodate responders who receive their medical monitoring exam from one of the Clinical Centers and receive their treatment services through the NRHP contractor’s nationwide network.

The NRHP contractor’s proposal shall describe how they would handle this situation, including the transfer of medical records.

The NRHP contractor’s health care provider network shall contain health care providers at convenient locations so that a minimum of 95% of national responders in an urban setting will have to travel no more than 30 miles to the closest primary care provider and a minimum of 90% of national responders in a rural setting will have to travel no more than 75 miles to the closest primary care provider. It is realized, however, that there may be instances where travel distance may be longer. These instances will be addressed on a case by case basis and final solutions negotiated between the NRHP contractor and NIOSH. Section J contains city-level Zip Codes for current NRHP responders.

Health Care Provider Network

The WTC RHP NRHP health care provider network shall consist of the NRHP contractor’s national network of providers who will provide medical monitoring examinations, diagnosis, and treatment to all NRHP responders. All services shall be provided outside of the NYC area.

During the Transition-in Phase the NRHP contractor shall provide all the necessary procedures, personnel and systems to establish this network of health care providers.

Certification and Credentialing

During the Transition-in Phase the NRHP contractor shall ensure that all providers in the contractor’s nationwide provider network are properly licensed under applicable state laws and/or regulations and are properly insured. Additional specifications may be required to certify competency of the physicians proposed by the NRHP contractor to perform the medical monitoring exams. Final solutions will be negotiated between NRHP contractor and NIOSH.

C.4.1.5.1 Readiness Review

The NRHP contractor shall develop new, or revise existing operating procedures and associated documentation, if required, to support the NRHP contractor’s proposed approach to conducting operations activities in compliance with the contract. The NRHP contractor shall maintain a NRHP Contract Operations Manual which documents all policies and procedures to be used in the performance of this contract. The NRHP contractor shall deliver a copy of the draft NRHP Contract Operations Manual to NIOSH for approval by the end of the Transition-in Phase and shall ensure throughout the contract that NIOSH has the most current version of the manual by sending to NIOSH the most current version of the Operations Manual on a monthly basis.

Within 3 weeks of the award of the contract, the NRHP contractor shall develop and submit a Draft Coordination Plan to NIOSH that documents how the NRHP contractor shall coordinate its business activities with those activities performed by NIOSH and those performed by the medical monitoring exam, diagnosis, and focused treatment providers outside of the NYC area.

Based on interaction with NIOSH, the NRHP contractor’s Coordination Plan shall be finalized by the end of the Transition-in Phase.

Testing for System Compatibility for Claims Processing and Bill Payment

The NRHP contractor shall accept into its system test data files and information available from health care providers and pharmacy benefit providers and send the results or these tests to NIOSH to verify data compatibility.

C.4.1.5.2 Assurance of System and Operational Readiness

By the conclusion of the Transition-in Phase, the NRHP contractor shall ensure to NIOSH, in writing, that all processes, data systems, and staffed functions are ready and able to successfully assume responsibilities for operations prior to the start of the Operations Phase. The NRHP contractor shall assure that Key Personnel, service staff, and data management staff are hired and trained; data management systems and interfaces are in place and functioning properly; and communication procedures are in place. The NRHP contractor shall assure that all business relationships are in place to provide all required health care services.

C.4.1.6 Operations Phase

The Operations Phase is defined as that period between the end of the Transition-in Phase and the completion of the Contract. Operations Phase activities shall continue through the end of the Transition-out Phase. During the Operations Phase, the NRHP contractor shall be responsible for close communication with NIOSH and health care providers to ensure that all required services are provided.

The NRHP contractor’s NRHP Contract Operations Manual shall contain the policies and procedures used by the NRHP contractor to meet all contract requirements during the Operations Phase and shall addresses, at a minimum:

• Overall Project Management

• Initial and Annual Medical Monitoring Examinations

• Diagnostic and Treatment Services

• Pharmacy Benefit

• Case Management

• Claims Processing and Bill Payment

• Member Services o WTC Phone Bank/Resource Line o WTC ID Cards o Member Retention o Member Transfers o Medical Review and Appeals o Social Services Referrals o Workers’ Compensation Assistance o Internal Audit Function o Media Relations o Records Management

• Reporting.

The Table of Contents of the current Operations Manual is contained in Section J. This Operations Manual is a work in progress and will need to be updated by the NRHP contractor to include all needed information.

The NRHP contractor shall be responsible for close communication with NIOSH. This shall include, at a minimum, participation in weekly project status meetings and participation in quarterly face-to-face project status meetings. The NRHP contractor’s Medical Director shall also participate in the Clinical Director's monthly meetings in New York City.

C.4.1.7 Transition-out Phase Requirements

The Transition-out Phase is defined as the activities the NRHP contractor shall perform prior to completion of the Contract, including the transition of contract operations to NIOSH or a subsequent contractor. During the Transition-out Phase, the NRHP contractor shall ensure that the WTC RHP, its members, health care providers, and other stakeholders do not experience any adverse impact from the transfer of services.

C.4.1.7.1 Transfer of Data and Information

As a part of the overall NRHP Contract Operations Manual, the NRHP contractor shall provide a Transition-out Plan that addresses transfer of data and information (including all medical records) and turnover of services.

The NRHP contractor shall transfer to NIOSH or a subsequent contractor all data and information necessary to transition operations, including: data and reference tables;

documentation relating to software and interfaces; functional business process flows; and operational information, including correspondence, documentation of ongoing or outstanding issues, operations support documentation, and operational information regarding subcontractors.

For purposes of this provision, "documentation" means all operations, technical and user manuals used in conjunction with the software, services and deliverables, in whole or in part, that NIOSH determines are necessary to view and extract application data in a proper format. The NRHP contractor shall provide the documentation in the formats in which such documentation exists at the expiration or completion of the contract.

The NRHP contractor shall provide to NIOSH all data, information and services necessary and sufficient to enable NIOSH to map all data from the NRHP contractor’s system(s) to the replacement system(s) of NIOSH or a successor contractor, including a comprehensive data dictionary.

The NRHP contractor shall provide to NIOSH all necessary data, information and services in the format defined by the NIOSH WTC Project Officer, and must be HIPAA compliant. All of the data, information and services mentioned in this section shall be provided and performed in a manner by the NRHP contractor using its best efforts to ensure the efficient administration of the WTC RHP. The data and information must be supplied in media and format specified by the NIOSH WTC Project Officer and according to the schedule approved by NIOSH. All relevant data and information must be received and verified by NIOSH. Failure to perform this requirement will be considered as contract non-compliance.

C.4.1.7.2 Turnover Services

Sixty (60) to Ninety (90) days prior to the end of the contract period the NRHP contractor shall propose a Turnover Plan. The Turnover Plan shall be a comprehensive document detailing the proposed schedule, activities, and resource requirements associated with the Transition-out Phase tasks. The Turnover Plan shall describe the NRHP contractor’s policies and procedures that will ensure:

• The least disruption in the delivery of health care services to those members who are enrolled in the WTC RHP during the transition to a subsequent contractor;

• Cooperation with NIOSH and the subsequent contractor in notifying WTC NRHP members of the transition and of their possible options, as requested and in the form required or approved by NIOSH; and

• Cooperation with NIOSH and the subsequent contractor in transferring information to the subsequent contractor, as requested and in the form required or approved by NIOSH.

At the close of the contract the NRHP contractor shall provide NIOSH with a Transition-out Phase Results Report documenting the completion and results of each step of the Turnover Plan.

The Transition-out Phase will not be considered complete until this document is approved by the NIOSH WTC Project Officer.

C.4.2 Initial and Annual Medical Monitoring Examinations

Initial and annual medical monitoring examinations shall be provided to all members of the NRHP. It is expected that medical monitoring examinations shall be conducted by a qualified physician specializing in Occupational Medicine. Exceptions to allow other qualified physicians to conduct the medical monitoring exam may be granted for responder convenience reasons. The multi-staged medical monitoring process is diagramed in Figure C.4.2-1.

Monitoring Appointments

• Outreach to Responder

• Prior monitoring records obtained

• Responder given appointments

Medical History

Pre-clinical encounter via computer-assisted interviewing, data collection

• Telephone interview

• Summary to MD

Medical Testing

• CBC, blood chemistries

• Urinalysis

• Screening PFT

• Chest x-ray

Provider Office Visit

Physician receives report of medical history + medical tests

• Conducts clinical interview

• Physical exam

• Clinical synthesis

Encounter Map with Credentialed Clinicians

Patient-Focused Physician Counseling

• Discuss findings, assessment and referral instructions

Records Retained (continuity over time)

• Physician Summary Report

• Medical test results

• Referrals

Case Manager

• Patient advocacy

• Coordination of care

Clinician Hotline Support (assessment, referral)

Medical Quality and Control

Treatment for WTC-covered conditions

Social benefits counseling

Quality Control for PFT

Figure C.4.2-1 Medical Monitoring Process

Currently, the medical monitoring exam for NRHP responders is being conducted in three phases. The first phase is a Medical History Questionnaire (MHQ) which is conducted by telephone, by a Registered Nurse employed by the contractor and at the contractor’s location.

The MHQ typically takes approximately 45 minutes to complete. The current MHQ for the medical monitoring examination is contained in Section J. The second phase is a work-up appointment where the member undergoes the requisite testing (pulmonary function test, chest radiograph, blood and urine assays). The current QA requirements for the PFT tests are contained in Section J. Once the first two phases are complete, a summary report is prepared for the physician who conducts the physical examination in the third phase of the process. This summary report contains information from the MHQ and the work-up appointment plus a summary of past medical records. The current Physician’s Summary Report is contained in Section J. The NRHP contractor shall ensure that the physician who conducts the physical examination has a copy of the summary report in time to review it before conducting the responder’s physical examination. The third phase is the physician encounter, including review of the responder’s medical history and test results (summary report) and a physical examination.

The current Physical Exam Form is contained in Section J. The NRHP contractor shall be responsible for scheduling all three phases of the Medical Monitoring process. Approximately 2,300 medical monitoring exams were conducted in the past year in the NRHP.

Note: A representative sampling of 10% of the PFT results shall be sent to a NIOSH-selected PFT QA representative each month.

During the medical monitoring exam, if no illness is diagnosed, or if the illness is determined not to be WTC-related, or if it is determined that no treatment is required, the responder shall be tentatively scheduled for a subsequent medical monitoring exam by the NRHP contractor.

Responders shall be scheduled for medical monitoring exams every 12 months.

If the medical monitoring exam reveals an illness that is on the list of WTC covered conditions and requires treatment or if the medical monitoring exam reveals the need for additional diagnostic testing to confirm a condition that is on the list of WTC covered conditions, the NRHP contractor's Medical Director shall oversee a referral for the NRHP responders to a treatment provider in the NRHP contractor’s provider network. The NRHP contractor shall assist the NRHP responders with scheduling appointments with appropriate treatment providers. The current Covered Condition Referral Form is contained in Section J. The current Non-Covered Condition Recommendation Form is contained in Section J.

As a part of the medical monitoring examination for responders in the NRHP, the NRHP contractor shall accomplish the following tasks:

• Scheduling the exam for the member with a provider in the NRHP contractor’s network

• Summarizing prior medical records (including prior claims information) and ensuring that the medical monitoring exam physician has a copy of the summary report prior to the scheduled physical exam appointment

• Conducting the Medical History Questionnaire Interview using Registered Nurses

• Performing the required lab work and a chest radiograph (if required)

• Performing PFTs which meet the performance requirements found in Section J

• Ensuring that the medical monitoring physician has a summary of the Medical History

Questionnaire Interview, a summary of the prior treatment records, if available, and the prior medical monitoring exam records in time for the scheduled physical exam

• Reporting the results of the medical monitoring examination to the responder

• Ensuring that medical monitoring examinations are coded correctly and that claims are paid promptly

• Coordinating referrals for further diagnosis of suspected WTC-approved conditions

• Coordinating referrals for treatment (including medications) of approved WTC conditions

• Advising the NRHP responder to seek care outside the program for Non-WTC-covered conditions

• Providing WTC RHP Benefits Counseling

• Providing Social Services referrals

• Performing quality assurance checks on the medical monitoring process and the appropriateness and completeness of the medical records.

In addition, the NRHP contractor shall develop and implement procedures to handle emergency situations or manage crises that may arise during monitoring, treatment, case management, or other responder interaction. The NRHP contractor is expected to educate and train their staff and network providers in the proper completion of paperwork, the limitations of coverage, and disseminate scientific information regarding WTC exposures and related health outcomes.

When a medical monitoring exam has been completed by a provider in the NRHP contractor’s national network, the NRHP contractor shall ensure that a copy of all completed medical monitoring exam documents and results are sent to the NRHP contractor. Following a medical monitoring exam, the exam provider will also submit a CMS1500 Form (or similar form) to the NRHP contractor. Following a medical monitoring exam, the NRHP contractor shall be responsible for sending a letter to the responder informing them of the exam results. The NRHP contractor shall verify that a complete medical monitoring exam has been conducted (including the letter to the responder), process the claim, pay the bill, and enter the appropriate data into their database.

The NRHP contractor shall develop procedures for the following medical monitoring exam-related issues. These procedures shall be submitted to NIOSH for approval as a part of the NRHP Contract Operations Manual prior to the end of the Transition-in Phase (see the Project Management section).

• Scheduling medical monitoring exams

• Conducting all components of the medical monitoring examination

• Ensuring that the proper data is sent to the NRHP contractor from a medical monitoring exam conducted by a provider in the NRHP contractor’s network

• Ensuring that a letter is sent to the responder informing them of the exam results within two weeks of the completion of the monitoring exam

• Processing and paying claims for all medical monitoring exam-related services

• Collecting all data required for project management and reporting.

C.4.3 Diagnostic and Treatment Services

Diagnostic and treatment services for responders outside the NYC area (NRHP responders) shall be provided through the NRHP contractor’s nationwide provider network. Currently, approximately 900 responders are receiving treatment services in the NRHP.

If it is determined from the medical monitoring exam that the NRHP responder does not need further diagnosis or treatment, the NRHP contractor shall be responsible for scheduling the next medical monitoring exam. Medical monitoring exams are to be conducted on an annual basis.

The NRHP contractor shall also provide WTC RHP benefits counseling and social service referrals whenever needed.

If it is determined from the medical monitoring exam that the responder needs additional diagnostic assessment or treatment services for a health condition covered by the WTC program, the NRHP contractor shall be responsible for providing an appropriate treatment referral, which will be scheduled by the NRHP contractor. The NRHP contractor will assign a qualified medical services provider within the NRHP contractor’s provider network. For responders already engaged in treatment with an out-of-network provider, the NRHP contractor will attempt to establish a business relationship with this provider, thereby adding this provider to their network or establishing comparable fees and an acceptable billing process. The NRHP contractor will ensure that the treatment provider is oriented to the specific health conditions, procedures, and medications covered by the program and appropriate procedures for handling non-covered health conditions, medical emergencies and program coverage appeals.

Following a diagnostic or treatment appointment, all providers will submit a CMS1500 Form (or similar form) and a Summary of Treatment form (found in Section J) to the NRHP contractor.

The NRHP contractor shall enter the appropriate data into their database. The NRHP contractor shall be responsible for paying the treatment provider once all required information has been received and confirmed.

In addition, the NRHP contractor’s database shall serve as a medical records locator. This function will facilitate the retrieval of all medical records from any provider the NRHP responder has seen. Since this database is based on claims data, the database shall contain information on all NRHP responders.

The NRHP contractor shall develop procedures for the following treatment-related issues:

• Coordinating referrals for further diagnosis of WTC covered conditions

• Coordinating referrals for treatment (including medications) of WTC covered conditions

• Explanation of benefits, including guidance to providers and participating members regarding referrals and services for non-WTC covered conditions

• Appeals process, including determination of medical necessity and criteria and procedure to secure an independent medical review

• Pre-authorization and utilization review for non-emergency inpatient services (i.e., overnight stay), and notification within 72 hours of emergency hospitalization for covered conditions

• Hospice and home care, if determined to be medically necessary for covered health conditions

• Treatment visit results reporting

• Coding and claims processing and payment for all diagnostic and treatment-related visits and services covered under the program

• Criteria and protocol to engage emergency services for medical and behavioral health crises.

These procedures shall be submitted to NIOSH for approval as a part of the NRHP Contract Operations Manual prior to the end of the Transition-in Phase (see the Project Management section).

C.4.4 Pharmacy Benefit

The NRHP contractor shall provide a nationwide pharmacy benefit to all members of the WTC NRHP. Benefits shall include but not be limited to retail prescription drug disbursement services, mail order pharmacy services, Drug Utilization Review (DUR) services, formulary management services, data management services, benefit management, call center and online membership services, and data reporting services.

C.4.4.1 Pharmacy Benefit Management Services

The NRHP contractor shall provide pharmacy benefit management and prescription drug disbursement services to all members of the WTC NRHP. The prescribing physician will submit a CMS1500 Form (or equivalent) to the NRHP contractor. The NRHP contractor shall enter the appropriate data into their database. The NRHP contractor shall be responsible for paying the medication provider once all required information has been confirmed.

C.4.4.2 Pharmacy Benefit Member Management

The NRHP contractor shall provide a real-time, secure, online Pharmacy Benefit Management System (PBM System) for administration and member management.

C.4.4.2.1 Pharmacy Claims Processing and Adjudication

The NRHP contractor shall provide claims processing and adjudication services for all services provided under the pharmacy benefit.

C.4.4.2.2 Pharmacy Paper Claims Processing

The NRHP contractor shall provide the capability to process paper claims.

C.4.4.2.3 Pharmacy Rebates and Discounts

The NRHP contractor shall provide rebate services to include but not be limited to the following:

• The NRHP contractor shall provide monthly review of the WTC RHP Formulary for opportunities to receive drug manufacturer rebate contracts and/or "bundling" contracts.

• The NRHP contractor shall provide a monthly rebate report listing each rebate.

• The NRHP contractor shall provide copies of all rebate contracts for WTC RHP formulary drugs within ten (10) business days of written notification from the NIOSH WTC Project Officer.

• Rebates shall be remitted as mutually agreed upon by NIOSH and the NRHP contractor, the NRHP contractor shall; however, pass-through all rebate payments made to and received from retail providers and vendors.

C.4.4.2.4 Pharmacy Analytic Services

The NRHP contractor shall provide analyses to include but not be limited to per member drug use, physician prescription per drug, per drug volume rates, rates of renewal per patient, rates of renewal per drug as well as monthly metrics as mutually agreed upon by the NRHP contractor and NIOSH.

C.4.4.2.5 Pharmacy Data Systems and Reporting

The NRHP contractor shall provide data systems and reporting services to include but not be limited to the following services:

• All data output to include all billing information and related data shall be exported in ASCII data file and Microsoft Excel file format and shall be delivered in the format expressly requested by NIOSH.

• The NRHP contractor shall provide weekly and monthly metrics and usage reports to measure patient drug use, prescriptions per drug per physician, per drug volume rates, rates of renewal per patient, rates of renewal per drug, and additional monthly metrics as directed by NIOSH.

C.4.4.2.6 Pharmacy Benefit Fraud and Abuse/Compliance

The NRHP contractor shall conduct on-site and desktop fraud and abuse audits of the participating pharmacy network as required and not less than one (1) time per year and/or upon request by NIOSH.

The NRHP contractor shall commence investigation of a fraud or abuse complaint within one (1) business day of receipt of notification. The NRHP contractor shall provide NIOSH with a full report of the investigation of the alleged fraud or abuse complaint within ten (10) business days.

C.4.4.2.7 Pharmacy Financial Reporting

The NRHP contractor shall manage the transaction categories and provide complete and transparent reporting and associated financial processes to include but not be limited to:

• Recoupments

• Recoveries

• Voids

• Reprocessing

• Run-out claims (claims with date of service before cut off).

The NRHP contractor shall propose pharmacy benefit program strategies and techniques that shall maximize pharmacy-related savings to the Government.

C.4.4.2.8 Prescription Drug Disbursement Services

C.4.4.2.8.1 Nationwide Retail Pharmacy Network

The NRHP contractor shall provide a nationwide retail pharmacy network.

C.4.4.2.8.2 Mail Order Pharmacy

The NRHP contractor’s pharmacy benefit shall include a mail order pharmacy with online capabilities for managing prescription orders and refill request. Mail order pharmacy services shall provide prescribed medications no later than (3) business days after initial receipt of the national responder's prescription.

C.4.4.2.9 Prescription Refill Services

The NRHP contractor’s pharmacy benefit refill services shall include:

C.4.4.2.9.1 Prescription Refill Notification

The NRHP contractor shall notify the WTC NRHP member no later than thirty (30) days prior to the completion of a ninety (90) day prescription to process each refill prescription. Said notification shall be in the form of an email, letter, post card or other such means as recommended by the NRHP contractor and mutually agreed upon by the NRHP contractor and NIOSH. The NRHP contractor shall notify the member thirty (30) days prior to the completion of the third (3rd) refill prescription to ensure the national responder adequate time to seek a new prescription as required. Notification shall occur in the manner described above.

C.4.4.2.9.2 Refill Processing

The NRHP contractor shall provide an online or toll-free telephone prescription refill service to allow members to process their refills requests upon receipt of notification of a refill and/or at a minimum thirty (30) days prior to the completion of a prescription. The Mail Order refill services shall provide prescribed refill medication no later than three (3) business days after receipt of the refill request from the member.

C.4.4.2.10 Drug Utilization Review (DUR)

NIOSH has identified a formulary that shall be used for the treatment of medical conditions.

Section J contains this formulary. Medications listed in the formulary are subject to change at the sole discretion of NIOSH. Formulary changes shall be provided to the NRHP contractor by the NIOSH WTC Project Officer.

The NRHP contractor shall update the medical formulary of approved drugs within five (5) business days of receipt of the formulary changes.

The NRHP contractor shall provide and adjust the price schedule per medication within three (3) business days of receipt of the formulary changes. In the event there is no reference for determining the wholesale price of a drug as provided in the formulary, the parties shall mutually agree upon a reference for drug pricing to be used for this agreement. The NRHP contractor shall provide concurrent DUR services to NIOSH to include but not be limited to developing a protocol for managing:

• Drug-drug interactions

• Drug-patient interactions

• Drug-disease interactions

• Drug-pregnancy interactions

• Drug over utilization

• Duplicate therapy

• Addictive substances

• Long term hypnotics.

C.4.5 Case…